Sharing clinical data: A way forward for scientific research

Brenda Lau, 12 Apr 2017

The scientific community is urged to also appreciate those who generate high-quality data sets for others to analyse.

Dr Jeffery Drazen, editor-in-chief of the New England Journal of Medicine has called for a "culture change" in the scientific community about clinical trials during a two-day summit 'Aligning Incentives for Sharing Clinical Trial Data' in Boston.

Instead of putting researchers who author papers on the pedestal, he urged the scientific community to also appreciate those who generate high-quality data sets for others to analyse. The summit saw an attendance of 140 patients, data scientists and researchers who conduct clinical trials, along with thousands who followed via an online live stream.

The main question of the day was: What and how can the right balance be struck between sharing data from clinical trials and fulfilling confidentiality requirements?

Data sharing not as simple as it seems

This call has recurred since more than a decade ago but it has gotten louder these two years. Many scientists agree that there are many advantages to data sharing such as the development of predictive models for patient selection, appropriate treatments or doses based on patient characteristics, and different therapies could be compared to without the expense of direct comparison trials.

But many researchers are still reluctant. For example, when a researcher collects data he or she has put a lot of effort in to understand the data and has no expectations that the data will be reused.

Therefore when others utilise the data set, the researchers worry that they are not responsible or will not use the data wisely enough. Others are worried at the possibility of "research parasites" who do not actually conduct studies, but instead leech off of others' data, producing results first.

Data sharing also costs money and a blanket requirement to upload data could also result in a number of data sets that would not be used.

"It is going to come at a financial cost, and if the financial cost is not worth the benefit for all trials, we should invest that time, money, and energy into doing more clinical trials,” said PJ Devereaux, a professor at McMaster University who has run clinical trials.

Tipping the balance of data sharing might lead to more complications

While patients agree that data should be shared early, often and responsibly, scientists have to come up with a way that will bypass confidentiality and privacy problems of sharing patient data.

In Europe, the European Medical Agency (EMA) has said that if someone asks for de-identified patient-level data, they "will make it available". Particularly for drug companies, the EMA will enforce a rule stating that all clinical trials data submitted to the agency will be available to the public and should not include protected patient health information that could be used to identify individuals.

But this could also lead to phantom risk and health scares as other researchers can examine and verify or disprove the conclusions.

Neither regulators nor industry like to be blindsided by reports that a drug or vaccine has an unreported side effect, but Hans-Georg Eichler, senior medical officer of EMA predicts that many licensed drugs could be targets for such re-analyses, leading to more complications.

Encouraging researchers to share data through data authorship

However, if public data sharing indeed has more pros than cons, the scientific community will have to find a method to protect data, yet encourage each other to submit data for sharing.

One of the main challenges is that data sharing does not have the fame and fortune that is often seen when papers are published in journals like Drazen's.

“We need to come up with better ways to give academic credit to people that generate data sets that lead to lots of important ideas and are used by lots of important people,” Drazen said.

He also urged medical school deans and promotion committees to recognise data generation in the same regards as publications for career decisions like hiring, promotion and tenure.

Journals as well, can request for authors to commit to sharing data behind their analyses within at least six months of submission, Drazen proposed in January 2016. The proposal still has not yet been adopted, but is currently being reviewed before a newer version is released this spring or summer.

“In this time, in this day and age, there’s a concern about what is the truth,” Drazen concluded at the summit. “And I think that having data out there in the public, even if it’s not re-analysed by lots of people … makes it more believable than if you say, ‘Trust me, I’m a doctor.’” MIMS

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